JP2015112360A - Medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To allow adjustment of the inclination angle of a shaft having a guide hole for insertion of an insertion member formed therein and also guide of the introduction of the insertion member into a human body, to be performed precisely and easily by a small and simplified configuration.SOLUTION: A medical instrument 30 comprises: a base 31; a shaft 32 which is arranged swingably around a fulcrum part 322 and has a guide hole 321 formed therein; a mainframe 33 connected to the base 31; a first subframe 34 mounted movably in the X direction on the mainframe 33 and having a first engaging hole 341 through which the shaft 32 is inserted while regulating the change of the inclination angle of the shaft 32 viewed from the Y direction and at the same time permitting the change of the inclination angle viewed from the X direction; and a second subframe 35 mounted movably in the Y direction on the mainframe 33 and having a second engaging hole 351 through which the shaft 32 is inserted while regulating the change of the inclination angle of the shaft 32 viewed from the X direction and at the same time permitting the change of the inclination angle viewed from the Y direction.

Description

  The present invention relates to a medical device that guides introduction of an insertion member such as a catheter into a body, and particularly to continuous delivery of a substance into a living tissue, in particular, increased convection delivery of a therapeutic substance into the brain parenchyma. The present invention relates to a medical instrument used.

  In recent years, for malignant glioma (glioblastoma, anaplastic astrocytoma, etc.), in addition to surgical therapy and radiation therapy, various therapies such as chemotherapy, immunotherapy, gene therapy, molecular target therapy, etc. Attempts have been made to improve the outcome of malignant brain tumors, including glioma. However, the most malignant glioblastoma has a low 5-year survival rate of about 7% and still has the poorest prognosis among all cancers.

  The basis of treatment for malignant glioblastoma is the possible removal of the tumor by surgery. However, because the brain performs various functions depending on the region, it is often impossible to remove the tumor sufficiently. In particular, in malignant glioblastoma, since tumor cells infiltrate the surrounding brain tissue, total excision at the tissue level is impossible. Therefore, radiotherapy and chemotherapy are indispensable as postoperative adjuvant therapy to improve the treatment outcome of malignant glioblastoma.

  Chemotherapy for malignant glioma has not yet been sufficiently effective despite its proven utility. In brain tumors, when a therapeutic drug is administered intravenously, the therapeutic drug is permeated through the blood brain barrier (BBB), so there is an inherent problem of permeability, and applicable drugs are limited. . Furthermore, even if BBB permeability is obtained, the drug dosage is limited due to concerns about side effects to the whole body caused by the drug, and an effective drug concentration cannot be ensured at the tumor site.

  A convection-enhanced delivery (CED) method has been devised as a new drug administration method for overcoming the problems of chemotherapy for malignant glioma as described above (for example, see Patent Document 1). . The CED method is local chemotherapy in which a drug is actively infused from a catheter placed stereotaxically in the brain parenchyma using a microinfusion pump. In the conventional local administration technique to the central nervous system, the distribution of the drug depends on the diffusion of the substance, whether it is intracavitary administration to the tumor excision cavity or a local chemotherapeutic agent placed in the brain. The diffusion of substances is defined by concentration gradients and tissue properties, and even a low-molecular compound with good diffusivity is considered to have a range of only a few millimeters due to absorption and metabolism in capillaries. This is inadequate for 80-90% of malignant glioma recurrences occurring within 2 cm of the initial lesion. On the other hand, in the CED method, the pressure gradient during the injection is maintained to induce a bulk flow between the cerebral cortex and enhance the diffusion of the injected substance. Therefore, compared with the conventional local administration method, the drug can be distributed more uniformly and at a high concentration over a wide range. In addition, the distribution of the drug in the brain can be controlled by the injection volume and the injection speed, and it is possible to reduce the dose compared to the systemic administration by vein, so that systemic side effects can be suppressed to a level where there is no problem. Is possible. There are a wide variety of drugs that can be administered by the CED method, and various drugs have been tried in rat brain tumor transplantation models, and their effectiveness has been reported. Because of these advantages, the CED method is expected as a method for treating not only brain tumors but also Parkinson's disease, Alzheimer's disease, epilepsy and the like.

  However, several problems remain to apply the CED method widely to clinical application. One is to ensure that the catheter reaches the target site. Usually, a technique is adopted in which the head is imaged by MRI, the position of the target part is confirmed, the position is aligned using a stereotaxic brain frame as a medical instrument, and the catheter is inserted.

  As a stereotaxic brain frame that can be MRI-compatible and fixed to the skull, Patent Document 1 discloses an MRI guided intervention system including an actuator that enables operation of the frame. In this technique, the frame is configured to translate and rotate so that a target cannula with a guide hole can be positioned relative to the desired body trajectory. This makes it possible to position a catheter or the like inserted through the target cannula with respect to the planned in-vivo trajectory.

  Patent Document 2 discloses a system for delivering a therapeutic agent into the cranium. In this technique, positioning is performed by connecting a trajectory guide through which an insertion device including an obturator, a sleeve, a therapeutic agent, and the like is connected to a mount at a lower end portion thereof by a ball joint mechanism. The obturator and the sleeve can be used to deliver a solid therapeutic agent to the target site.

Special table 2010-528863 Special table 2009-544406 gazette

However, although the technique described in Patent Document 1 is considered to allow precise movement and positioning of a target cannula (shaft) having a guide hole through which a catheter or the like is inserted, there are many movable parts and the configuration is complicated and complicated. Yes, the operation procedure is complicated.
The technique described in Patent Document 2 adjusts the angle of a trajectory guide (shaft) having a guide hole by a ball joint mechanism. The trajectory guide is precisely positioned only by the ball joint mechanism at the lower end. It is difficult.

  The present invention has been made in view of the above-described circumstances, and with a small and simple configuration, adjustment of the inclination angle of the shaft formed with the guide hole through which the insertion member is inserted, and consequently introduction of the insertion member into the body. It is an object of the present invention to provide a medical instrument capable of performing guidance accurately and easily.

  In order to solve the above problems, the present invention is a medical instrument for guiding the introduction of an insertion member into the body, wherein an opening through which the insertion member is inserted is formed and fixed to a patient's body, A shaft having an fulcrum portion at the end on the base side and arranged so as to be swingable around the fulcrum portion, and having an axial guide hole through which the insertion member is inserted, and connected to the base, A main frame having a frame that surrounds the side of the shaft while allowing the shaft to swing, and a direction along the central axis of the opening as a Z direction and two directions perpendicular to the Z direction perpendicular to each other as X When the direction and the Y direction are set, the shaft is attached to the main frame so as to be movable in the X direction, and the change in the inclination angle of the shaft viewed from the Y direction is restricted, while the inclination angle of the shaft viewed from the X direction is restricted. change of A first sub-frame having a first engagement hole through which the shaft is inserted, and is attached to the main frame so as to be movable in the Y direction, and restricts a change in the inclination angle of the shaft as viewed from the X direction. On the other hand, a second sub-frame having a second engagement hole through which the shaft is inserted while allowing a change in the inclination angle of the shaft viewed from the Y direction is provided.

According to such a configuration, the shaft is easily set to a desired inclination angle by moving the first subframe in the X direction with respect to the main frame and the second subframe in the Y direction with respect to the main frame. can do.
That is, a medical instrument capable of precisely and easily adjusting the inclination angle of the shaft formed with the guide hole through which the insertion member is inserted, and thus guiding the introduction of the insertion member into the body, with a small and simple configuration. Can be provided.

  Further, the present invention is characterized in that the fulcrum portion of the shaft has a spherical shape and is engaged with an engagement portion provided on one of the main frame and the base and having a concave inner surface. .

  According to such a structure, a shaft can be rock | fluctuated simply and reliably using a ball joint mechanism.

  In the present invention, the first sub-frame has a pair of first concave grooves provided on a pair of opposed inner side surfaces along the Y direction of the first engagement hole, and the second sub-frame includes And a pair of second concave grooves respectively provided on a pair of opposed inner side surfaces along the X direction of the second engagement hole, and the shaft is slidably inserted into the pair of first concave grooves. A first sphere having a through hole is engaged, and a second sphere having a through hole into which the shaft is slidably fitted is engaged with the pair of second concave grooves. .

  According to such a configuration, when the first subframe is moved in the X direction, the shaft slides in the axial direction in the through holes of the first sphere and the second sphere, and the second sphere through which the shaft is inserted. Moves in the X direction along the second concave groove of the second subframe. Further, when the second subframe is moved in the Y direction, the shaft slides in the axial direction in the through holes of the first sphere and the second sphere, and the first sphere through which the shaft passes is the first subframe. It moves in the Y direction along the first concave groove. Thereby, the inclination angle of the shaft viewed from the Y direction and the inclination angle of the shaft viewed from the X direction can be adjusted more precisely and easily.

  In the present invention, the first sub-frame includes a first guide hole along the X direction formed at one end in the Y direction and a first guide hole along the X direction formed at the other end in the Y direction. The second sub-frame has a second guide hole along the Y direction formed at one end in the X direction and a Y direction formed at the other end in the X direction. A first guide rod along the X direction that is slidably fitted into the first guide hole inside the frame body of the main frame, and is screwed into the first screw hole. A first male screw member along the X direction, a second guide rod along the Y direction slidably fitted into the second guide hole, and a Y direction screwed into the second screw hole Each of the second male screw members is attached.

  According to such a configuration, by rotating the first male screw member, the first subframe can be easily and reliably moved in the X direction by the screw feeding action. Further, by rotating the second male screw member, the second subframe can be moved in the Y direction easily and reliably by the screw feeding action.

  According to the present invention, the main knob includes a first knob connected to the first male screw member and rotatable by an operator, and a second knob connected to the second male screw member and rotatable by the operator. It is arrange | positioned at the side of the said frame.

  According to such a configuration, the operator easily rotates the first male screw member and the second male screw member by operating the first knob and the second knob arranged on the side of the frame. And the operability is improved.

  Further, in the present invention, a fixing mechanism for fixing an axial position of the insertion member inserted through the guide hole of the shaft is provided at an end portion of the shaft opposite to the base, and the fixing mechanism is An annular elastic member having a hole through which the insertion member is inserted when the insertion member is inserted into the guide hole, and a pressing member that presses the elastic member in the axial direction to reduce the inner diameter of the hole. And

  According to such a configuration, the insertion member inserted into the guide hole of the shaft can be held at a desired axial position. Thereby, it can prevent that the axial direction position of an insertion member shifts | deviates by the operation | work after the insertion to the shaft of an insertion member.

  Further, the present invention is characterized in that the insertion member is a catheter.

  According to such a structure, it becomes possible to inject | pour substances, such as a chemical | medical agent, accurately into the target site | part in a body through a catheter.

  Further, the present invention is characterized in that the introduction of the insertion member into the brain is guided.

  According to such a configuration, for example, increased convection delivery of a substance to the brain through the insertion member can be appropriately performed.

  According to the present invention, it is possible to adjust the inclination angle of the shaft formed with the guide hole through which the insertion member is inserted and to guide the introduction of the insertion member into the body with a small and simple configuration. A medical device can be provided.

It is a figure showing composition of a medicine administration system to which a medical instrument concerning one embodiment of the present invention was applied. It is a longitudinal cross-sectional view of the medical instrument shown by FIG. It is sectional drawing which follows the CC line of FIG. It is sectional drawing which follows the BB line of FIG. (A) is a partial expanded sectional view which shows the time of insertion to the guide hole of a catheter, (b) is a partial expanded sectional view which shows the time of fixation of the axial direction position of the catheter by a fixing mechanism. It is sectional drawing of the medical instrument which shows the state in which the shaft inclined.

Embodiments of the present invention will be described in detail with reference to the drawings as appropriate.
Note that, in the drawings shown below, the same members or corresponding members are denoted by the same reference numerals, and redundant description is omitted as appropriate. In addition, the size and shape of the member may be schematically represented by being modified or exaggerated for convenience of explanation.

  FIG. 1 is a diagram illustrating a configuration of a drug administration system 100 to which a medical device 30 according to an embodiment of the present invention is applied. In the present embodiment, a case will be described in which the drug administration system 100 is used for continuous delivery of a substance into a living tissue, in particular, increased convection delivery of a therapeutic substance into the brain parenchyma.

  As shown in FIG. 1, a drug administration system 100 includes a catheter (insertion member) 10 that is a tubular body having an insertion portion 11 introduced into a body that is a living tissue such as brain parenchyma, and a catheter 10. A medical instrument 30 that guides introduction into the body and a substance supply device 70 that supplies the substance into the catheter 10 are provided. The substance to be supplied for administration into the body is here a therapeutic substance, and a liquid such as a liquid (liquid drug) containing a drug is used.

  The substance supply device 70 includes a syringe 71 that houses a substance to be supplied and has a delivery port through which the substance is delivered, and a microinjection pump 72 that pumps the substance in the syringe 71 from the delivery port. Yes. The proximal end of the liquid feeding tube 60 is connected to the delivery port of the syringe 71 of the substance supply device 70. The distal end of the liquid feeding tube 60 is connected to a hub 50 attached to the proximal end of the catheter 10.

  FIG. 2 is a longitudinal sectional view of the medical instrument 30 shown in FIG. 2 corresponds to a cross-sectional view taken along line AA in FIG. 3 is a cross-sectional view taken along the line CC of FIG. 4 is a cross-sectional view taken along line BB in FIG.

As shown in FIGS. 2 to 4, the medical device 30 includes a base 31 fixed to a skull 90 as a patient's body, and a fulcrum 322 at an end (lower end) on the base 31 side. The shaft 32 is provided so as to be swingable about the portion 322, and the main frame 33 is connected to the base 31.

  The base 31 is a disc-shaped substrate 311 and a cylindrical guide 312 provided on a surface opposite to the main frame 33 of the substrate 311 and inserted into a bar hole (burr hole) 91 opened in the skull 90; It has a cylindrical base side connection portion 313 provided on the surface of the substrate 311 on the main frame 33 side to which the main frame 33 is connected.

  In the center of the substrate 311, an opening 314 is formed through which the catheter 10 (see FIG. 1, the same applies hereinafter) is inserted. In the present specification, for the sake of clarity, the direction along the central axis 316 of the opening 314 is defined as the Z direction, and the two directions perpendicular to the Z direction are defined as the X direction and the Y direction, respectively (FIG. 2). To FIG. 4).

  In the vicinity of the outer peripheral edge of the substrate 311, a plurality of (four in FIG. 3) through-holes 315 through which screw members 92 for fixing the base 31 to the skull 90 are inserted are formed at equal intervals along the circumferential direction. Yes. As a material of the screw member 92, for example, ceramic or resin is used. A female thread portion is formed on the inner peripheral surface of the base side connection portion 313.

  An axial guide hole 321 through which the catheter 10 is inserted is formed in the shaft 32. Further, the fulcrum portion 322 of the shaft 32 has a spherical shape, and is engaged with and engaged with an engaging portion 334 having a concave inner surface (spherical surface) 335. That is, the fulcrum part 322 and the engaging part 334 constitute a so-called ball joint mechanism. Here, the engaging portion 334 is provided in the main frame side connecting portion 332 as described later.

  When the fulcrum portion 322 of the shaft 32 is engaged with the inner surface 335 of the engagement portion 334, for example, the inner surface 335 of the engagement portion 334 can be slightly elastically deformed and enlarged. The pair of components may be joined after the fulcrum portion 322 is sandwiched between a pair of components configured by dividing the main frame side connection portion 332 provided with the engaging portion 334 into two parts.

  The main frame 33 includes a frame body 331 that surrounds the side of the shaft 32 while allowing the shaft 32 to swing, a main frame side connection portion 332 that is connected to the base side connection portion 313 of the base 31, and a frame body 331. And a connecting member 333 that connects the main frame side connecting portion 332 and these are joined together by, for example, adhesion.

  The frame body 331 is a frame having a C-shaped cross section and a square shape when viewed from the Z direction. A space 336 through which the shaft 32 is inserted and allows the shaft 32 to swing is formed in the frame body 331.

  On the outer peripheral surface of the main frame side connection portion 332, a male screw portion that can be screwed into the female screw portion on the inner peripheral surface of the base side connection portion 313 is formed. However, a male screw portion is formed on the outer peripheral surface of the base side connection portion 313, and a female screw portion that can be screwed to the male screw portion of the outer peripheral surface of the base side connection portion 313 is formed on the inner peripheral surface of the main frame side connection portion 332. The structure formed may be sufficient.

  Here, the engaging portion 334 is integrally formed with the main frame side connecting portion 332 of the main frame 33, but is not limited thereto. The engaging portion 334 may be formed integrally with the base side connecting portion 313 of the base 31. Moreover, although the connection member 333 is comprised from the some strip here, it is not limited to this, For example, you may be comprised from the funnel-shaped integral goods.

  The medical instrument 30 includes a first subframe 34 that is attached to the main frame 33 so as to be movable in the X direction, and a second subframe 35 that is attached to the main frame 33 so as to be movable in the Y direction. I have.

  The first sub-frame 34 regulates the change in the inclination angle (see FIG. 2) of the shaft 32 as seen from a point on the extension line in the Y direction, while the inclination angle of the shaft 32 as seen from a point on the extension line in the X direction A first engagement hole 341 (see FIG. 3) through which the shaft 32 is inserted while allowing a change in (see FIG. 4) is provided. Specifically, the first sub-frame 34 is a frame that is arranged on the XY plane and has a rectangular shape having a long side along the Y direction, and a pair of opposing first A-holes 341 along the Y direction. It is comprised so that the shaft 32 may be pinched | interposed from the side via the 1st spherical body 343 mentioned later by the inner side surface of this. Here, the inclination angle is an angle formed by the central axis 316 of the opening 314 of the base 31 and the central axis of the shaft 32 in a side view.

  The second subframe 35 regulates the change in the inclination angle (see FIG. 4) of the shaft 32 as seen from a point on the extension line in the X direction, while the inclination angle of the shaft 32 as seen from a point on the extension line in the Y direction. It has the 2nd engagement hole 351 (refer FIG. 3) which the shaft 32 penetrates, accept | permitting the change (refer FIG. 2). Specifically, the second subframe 35 is a frame that is arranged on the XY plane and has a rectangular shape having a long side along the X direction, and a pair of opposing second engagement holes 351 along the X direction. It is comprised so that the shaft 32 may be pinched | interposed from the side via the 2nd spherical body 353 mentioned later by the inner side surface of this.

  Further, the first sub-frame 34 has a pair of first concave grooves 342 and 342 (see FIG. 2) provided on a pair of opposed inner side surfaces along the Y direction of the first engagement hole 341 (see FIG. 3). Have. On the other hand, the second subframe 35 has a pair of second concave grooves 352 and 352 (see FIG. 4) respectively provided on a pair of opposed inner side surfaces along the X direction of the second engagement hole 351 (see FIG. 3). Have.

  A first sphere 343 having a through hole 344 into which the shaft 32 is slidably fitted is fitted and engaged with the pair of first concave grooves 342 and 342. In addition, a second spherical body 353 having a through hole 354 into which the shaft 32 is slidably fitted is fitted and engaged with the pair of second concave grooves 352 and 352. The engagement of the first sphere 343 with the pair of first concave grooves 342 and 342 can be performed, for example, while slightly elastically deforming and expanding the first engagement hole 341 of the first subframe 34. Note that the first sphere 343 may be sandwiched between a pair of parts configured by dividing the first subframe 34 into two parts, and then the pair of parts may be joined. The same applies to the engagement of the second sphere 353.

  Further, the first sub-frame 34 includes a first guide hole 345 along the X direction formed at one end portion in the Y direction and a first screw hole along the X direction formed at the other end portion in the Y direction. 346. The second sub-frame 35 includes a second guide hole 355 that is formed at one end in the X direction along the Y direction and a second screw hole that is formed at the other end in the X direction along the Y direction. 356.

  The first guide rod 361 is slidably inserted into the first guide hole 345 inside the frame body 331 of the main frame 33, and the X direction is screwed into the first screw hole 346. First male screw member 362, second guide rod 363 slidably fitted into second guide hole 355, and second male screw member along Y direction screwed into second screw hole 356 Each of the 364 is attached.

  On the side of the frame body 331 of the main frame 33, a first knob 365 connected to the first male screw member 362 and rotatable by the operator, and a first knob 365 connected to the second male screw member 364 and rotatable by the operator. Two knobs 366 are arranged.

  A fixing mechanism 37 that fixes the axial position of the catheter 10 (see FIG. 5) inserted through the guide hole 321 of the shaft 32 is provided at the end (upper end) of the shaft 32 opposite to the base 31.

  FIG. 5A is a partially enlarged cross-sectional view showing the catheter 10 being inserted into the guide hole 321, and FIG. 5B is a partially enlarged view showing when the axial position of the catheter 10 is fixed by the fixing mechanism 37. It is sectional drawing.

  As shown in FIG. 5, the fixing mechanism 37 includes an annular elastic member 371 having a hole 372 through which the catheter 10 is inserted when the catheter 10 is inserted into the guide hole 321 of the shaft 32, and the elastic member 371 in the axial direction. And a pressing member 373 that presses and reduces the inner diameter of the hole 372. For example, rubber or elastomer is used as the material of the elastic member 371.

  The pressing member 373 has a cap shape, and is disposed on a radially outer side of the pressing portion 376 and a cylindrical pressing portion 376 having an axial through-hole 374 through which the catheter 10 is inserted. And a cylindrical nut portion 375 having a female screw portion. Further, a male screw portion that can be screwed into a female screw portion of the nut portion 375 is formed on the outer peripheral surface of the upper end portion of the shaft 32. The shaft 32 may have a female thread portion and the pressing member 373 may have a male thread portion. Therefore, by screwing the pressing member 373 into the upper end portion of the shaft 32, the distal end of the pressing portion 376 presses and compresses the elastic member 371 in the axial direction, and the side surface of the catheter 10 has a reduced hole 372 in the elastic member 371. Can be held by the inner surface. The nut portion 375 is not limited to a screw structure that can be screwed. For example, the shaft 32 and the pressing member 373 may have a locking portion that locks the pressing member 373 stepwise with respect to the shaft 32 by providing a plurality of concave portions and convex portions.

  Reference numeral 20 in FIG. 5 indicates a stopper. The stopper 20 has a hole through which the catheter 10 passes, and can be held at an arbitrary position in the axial direction of the catheter 10 by lightly sandwiching the side surface of the catheter 10 with the inner surface of the hole. Accordingly, when the stopper 20 abuts on the fixing mechanism 37, insertion of the catheter 10 into the guide hole 321 of the shaft 32 is restricted.

  For example, a resin or a ceramic is used as a material of a part that is not particularly described as a material among the parts constituting the medical instrument 30. However, in the present embodiment, any material that does not cause artifacts in an image obtained by MRI can be used as appropriate.

Next, a method of using the medical instrument 30 configured as described above will be described together with its operation.
First, an operator such as a doctor installs the base 31 on the skull 90 so that the guide 312 of the base 31 is located in the bar hole 91 opened in the skull 90 and fixes it using the screw member 92. To do.

  Subsequently, the operator connects the main frame 33 on which the shaft 32, the first subframe 34, and the second subframe 35 are mounted to the base 31. Connection of the main frame 33 to the base 31 is performed by screwing the female screw portion of the main frame side connection portion 332 into the male screw portion of the base side connection portion 313. The main frame 33 may be connected to the base 31 first, and then the base 31 to which the main frame 33 is connected may be fixed on the skull 90.

  Subsequently, the operator adjusts the inclination angle of the shaft 32 by turning the first knob 365 and the second knob 366. At this time, in the image obtained by MRI, the target site, for example, in the vicinity of the brain tumor in the brain parenchyma where the distal end of the insertion portion 11 (see FIG. 1) of the catheter 10 should be positioned, and the inclination angle of the shaft 32 are confirmed. Adjustments are made.

  When the adjustment of the inclination angle of the shaft 32 is completed, the operator inserts the catheter 10 into the guide hole 321 of the shaft 32 and inserts it into the target site in the brain parenchyma. When the hub 50 (see FIG. 1) has a three-way stopcock or a check valve, the liquid feeding tube 60 (see FIG. 1) is inserted into the hub 50 after the insertion portion 11 of the catheter 10 is placed in the body. You may connect to.

  When it is confirmed in the image obtained by MRI that the distal end of the insertion portion 11 of the catheter 10 has reached the target site, the operator uses the fixing mechanism 37 to fix the axial position of the catheter 10. At this time, the stopper 20 held by the catheter 10 comes into contact with the fixing mechanism 37.

  Then, the substance is supplied from the syringe 71 to the liquid feeding tube 60 by the operation of the microinjection pump 72. The substance delivered to the liquid delivery tube 60 passes through the hub 10 through the catheter 10 and is released from the distal end of the insertion portion 11 of the catheter 10 to the target site. Therefore, a substance such as a drug can be accurately injected into the target site in the body through the catheter 10. That is, it becomes possible to appropriately perform convection-enhanced delivery of a substance to the brain through the catheter 10.

  As described above, the medical device 30 according to the present embodiment is arranged so as to be swingable around the base 31, the fulcrum part 322, and the main 32 connected to the base 31 and the shaft 32 in which the guide hole 321 is formed. The shaft 32 is attached to the frame 33 and the main frame 33 so as to be movable in the X direction. The shaft 32 restricts a change in the inclination angle of the shaft 32 viewed from the Y direction while allowing the change of the inclination angle viewed from the X direction. The first sub-frame 34 having the first engagement hole 341 to be inserted and the main frame 33 are attached to the main frame 33 so as to be movable in the Y direction. And a second sub-frame 35 having a second engagement hole 351 through which the shaft 32 is inserted while allowing a change in the tilt angle seen.

Therefore, according to the present embodiment, the first sub-frame 34 is moved in the X direction with respect to the main frame 33, and the second sub-frame 35 is moved in the Y direction with respect to the main frame 33, so that the shaft 32 is tilted to a desired inclination. The angle can be easily set.
That is, a medical device capable of precisely and easily adjusting the inclination angle of the shaft 32 in which the guide hole 321 through which the catheter 10 is inserted is formed and thus guiding the introduction of the catheter 10 into the body with a small and simple configuration. An instrument 30 can be provided.

  Further, in the present embodiment, the fulcrum part 322 of the shaft 32 has a spherical shape, and is engaged with an engagement part 334 having a concave inner surface 335 provided on the main frame side connection part 332 of the main frame 33. . According to such a configuration, the shaft 32 can be swung easily and reliably using the ball joint mechanism.

  Further, in the present embodiment, the first sphere 343 having the through hole 344 into which the shaft 32 is slidably fitted is engaged with the pair of first concave grooves 342 of the first subframe 34, and the second subframe is engaged. A second spherical body 353 having a through hole 354 into which the shaft 32 is slidably fitted is engaged with the pair of second concave grooves 352 of 35. According to such a configuration, when the first subframe 34 is moved in the X direction, the shaft 32 slides in the through holes 344 and 354 of the first sphere 343 and the second sphere 353 in the axial direction, The second sphere 353 through which the shaft 32 is inserted moves in the X direction along the second concave groove 352 of the second subframe 35. As shown in FIG. 6, when the second subframe 35 is moved in the Y direction, the shaft 32 slides in the through holes 344 and 354 of the first sphere 343 and the second sphere 353 in the axial direction. The first sphere 343 through which the shaft 32 is inserted moves in the Y direction along the first concave groove 342 of the first subframe 34. Thereby, the inclination angle of the shaft 32 seen from the Y direction and the inclination angle of the shaft 32 seen from the X direction can be adjusted more precisely and easily.

  In the present embodiment, the first subframe 34 has a first guide hole 345 along the X direction and a first screw hole 346 along the X direction, and the second subframe 35 is a second along the Y direction. It has a guide hole 355 and a second screw hole 356 along the Y direction. The first guide rod 361 and the first screw hole 346 are inserted into the first guide hole 345 inside the frame body 331 of the main frame 33. A first male screw member 362 screwed into the second guide hole 355, a second guide rod 363 fitted into the second guide hole 355, and a second male screw member 364 screwed into the second screw hole 356 are respectively attached. . According to such a configuration, by rotating the first male screw member 362, the first subframe 34 can be easily and reliably moved in the X direction by the screw feeding action. Further, by rotating the second male screw member 364, the second sub-frame 35 can be moved in the Y direction easily and reliably by the screw feeding action. In addition, the precision of adjusting the inclination angle of the shaft 32 can be appropriately ensured by appropriately setting the pitch of the screw portion that causes the screw feeding action.

  Further, in the present embodiment, the first knob 365 connected to the first male screw member 362 and the second knob 366 connected to the second male screw member 364 are lateral to the frame body 331 of the main frame 33. Is arranged. According to such a configuration, the operator operates the first knob 365 and the second knob 366 arranged on the side of the frame body 331 to move the first male screw member 362 and the second male screw member 364. Each can be easily rotated to improve operability.

  In the present embodiment, a fixing mechanism 37 that fixes the axial position of the catheter 10 inserted through the guide hole 321 of the shaft 32 is provided at the end of the shaft 32 opposite to the base 31. According to such a configuration, the catheter 10 inserted into the guide hole 321 of the shaft 32 can be held at a desired axial position. Thereby, it can prevent that the axial direction position of the catheter 10 shifts | deviates by the operation | work after the insertion to the shaft 32 of the catheter 10. FIG.

  As mentioned above, although this invention was demonstrated based on embodiment, this invention is not limited to the structure described in the said embodiment, The combination thru | or selecting suitably the structure described in the said embodiment is included. The configuration can be changed as appropriate without departing from the spirit of the invention. In addition, a part of the configuration of the embodiment can be added, deleted, and replaced.

  For example, the connection method between the base side connection portion 313 and the main frame side connection portion 332 is not limited to the above-described screw fastening. A connection method using means for restricting and releasing movement may be employed.

  Further, in the first sub-frame 34, instead of forming a pair of first concave grooves 342 and 342 on the pair of opposed inner side surfaces along the Y direction of the first engagement hole 341, respectively, a pair of linear grooves An elastic member may be attached, and the shaft 32 may be sandwiched from the side by the inner side surfaces of the pair of elastic members. In this case, the installation of the first sphere 343 having the through hole 344 into which the shaft 32 is inserted is omitted. With such a configuration as well, it is possible to allow a change in the inclination angle of the shaft 32 as viewed from the X direction while restricting a change in the inclination angle of the shaft 32 as viewed from the Y direction. The same applies to the second subframe 35.

  Further, the medical device 30 may include a counter that measures and displays information related to the inclination angle of the shaft 32 such as the rotation angle and the number of rotations of the first male screw member 362 and the second male screw member 364. Good. If comprised in this way, adjustment of the inclination-angle of the shaft 32 will become easier. This counter may be installed between the first male screw member 362 and the first knob 365 and between the second male screw member 364 and the second knob 366, for example. Alternatively, signals such as the rotation angle and the number of rotations of the first male screw member 362 and the second male screw member 364 are sent to the computer, and the counter value is displayed on the display screen together with, for example, the MRI image. May be. At this time, instruction information such as the rotation angle and the number of rotations to be changed from the current state may be displayed on the display screen. The displayed counter value may be an inclination angle of the shaft 32 obtained by performing arithmetic processing on the raw data.

  Further, the medical instrument 30 may include a lock mechanism that locks the rotation of the first male screw member 362 and the second male screw member 364. As the locking mechanism, for example, a set screw that presses the side surface of the first male screw member 362 or the second male screw member 364 can be used. If comprised in this way, it can prevent reliably that the inclination-angle of the shaft 32 shifts | deviates.

  The medical device 30 can also be applied to guide introduction of other insertion members into the body, such as a medical device such as a stimulation lead, in addition to the catheter 10.

10 Catheter (insertion member)
DESCRIPTION OF SYMBOLS 30 Medical instrument 31 Base 314 Opening 316 Central axis 32 Shaft 321 Guide hole 322 Support point part 33 Main frame 331 Frame body 334 Engagement part 335 Inner surface 34 1st sub-frame 341 1st engagement hole 342 1st recessed groove 343 1st Sphere 344 Through hole 345 First guide hole 346 First screw hole 35 Second subframe 351 Second engagement hole 352 Second concave groove 353 Second sphere 354 Through hole 355 Second guide hole 356 Second screw hole 361 First Guide rod 362 First male screw member 363 Second guide rod 364 Second male screw member 365 First knob 366 Second knob 37 Fixing mechanism 371 Elastic member 372 Hole 373 Pressing member 90 Skull (body)

Claims (8)

A medical instrument for guiding the insertion of the insertion member into the body,
An opening through which the insertion member is inserted and a base fixed to the patient's body;
A shaft having a fulcrum portion at an end portion on the base side and arranged so as to be swingable around the fulcrum portion, and having an axial guide hole through which the insertion member is inserted;
A main frame having a frame connected to the base and surrounding a side of the shaft while allowing the shaft to swing;
When the direction along the central axis of the opening is the Z direction and the two directions perpendicular to the Z direction are the X direction and the Y direction, respectively, it is attached to the main frame so as to be movable in the X direction. A first subframe having a first engagement hole through which the shaft is inserted while restricting a change in the inclination angle of the shaft viewed from the direction while allowing a change in the inclination angle of the shaft viewed from the X direction;
The shaft is mounted so as to be movable in the Y direction with respect to the main frame, and restricts a change in the tilt angle of the shaft viewed from the X direction while allowing a change in the tilt angle of the shaft viewed from the Y direction. A second subframe having a second engagement hole through which is inserted;
A medical instrument comprising:   The said fulcrum part of the said shaft is exhibiting spherical shape, It is engaging with the engaging part which is provided in one of the said main frame and the said base, and has a concave inner surface. Medical instrument. The first subframe has a pair of first concave grooves respectively provided on a pair of opposed inner side surfaces along the Y direction of the first engagement hole,
The second subframe has a pair of second concave grooves provided on a pair of opposed inner side surfaces along the X direction of the second engagement hole,
A first sphere having a through hole into which the shaft is slidably fitted is engaged with the pair of first concave grooves,
The medical device according to claim 1 or 2, wherein a second sphere having a through hole into which the shaft is slidably fitted is engaged with the pair of second concave grooves. . The first sub-frame has a first guide hole along the X direction formed at one end in the Y direction and a first screw hole along the X direction formed at the other end in the Y direction. And
The second sub-frame has a second guide hole along the Y direction formed at one end in the X direction and a second screw hole along the Y direction formed at the other end in the X direction. And
A first guide rod along the X direction that is slidably fitted into the first guide hole inside the frame of the main frame, and a first guide along the X direction that is screwed into the first screw hole. A screw member, a second guide rod along the Y direction slidably fitted into the second guide hole, and a second male screw member along the Y direction screwed into the second screw hole are respectively attached. The medical instrument according to any one of claims 1 to 3, wherein the medical instrument is provided.   A first knob connected to the first male screw member and rotatable by an operator, and a second knob connected to the second male screw member and rotatable by the operator are on the frame side of the main frame. The medical instrument according to claim 4, wherein the medical instrument is disposed on the side. A fixing mechanism for fixing an axial position of the insertion member inserted into the guide hole of the shaft is provided at an end portion of the shaft opposite to the base,
The fixing mechanism includes an annular elastic member having a hole through which the insertion member is inserted when the insertion member is inserted into the guide hole, and a pressing member that presses the elastic member in the axial direction to reduce the inner diameter of the hole. The medical instrument according to any one of claims 1 to 5, wherein:   The medical instrument according to any one of claims 1 to 6, wherein the insertion member is a catheter.   The medical instrument according to any one of claims 1 to 7, which guides introduction of the insertion member into the brain.

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